What Does WTO Extension For LDCs To Enforce IP Mean For Pharmaceuticals?

The recent extension granted by World Trade Organization members to least developed countries giving 8 more years to implement international intellectual property protection rules threw a shroud of confusion over a parallel WTO waiver for pharmaceutical products conferred on least developed countries until 2016. In an attempt to shed some light on the issue, several experts were asked for their reflections on the consequences of the new extension.

The June 2013 extension for LDCs to enforce WTO IP rules will end on 1 July 2021. It temporarily waives the obligation of least developed countries (LDCs) to apply the provisions of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), except for articles 3 (national treatment), 4 (most-favoured-nation treatment), and 5 (multilateral agreements on acquisition or maintenance of protection) (IPW, WTO/TRIPS, 12 June 2013).

Since the newly passed extension is for the full TRIPS agreement, it could be considered to apply to all products, including pharmaceutical products.

Meanwhile, there is also a separate extension for LDCs for pharmaceutical products. The 2001 WTO Doha Ministerial Declaration on TRIPS and Public Health established that LDCs “will not be obliged, with respect to pharmaceutical products, to implement or apply sections 5 [patents] and 7 [protection of undisclosed information] of Part II [standards concerning the availability, scope and use of intellectual property rights] of the TRIPS Agreement or to enforce rights provided for under these Sections until 1 January 2016…”

Industry Perspective

Sara Käch, head of communications and spokesperson of Interpharma, a Swiss pharmaceutical association, said:

“Interpharma fully supports the position of the IFPMA [International Federation of Pharmaceutical Manufacturers & Associations].”

“When the issue was first raised in 2011, IFPMA supported the principle of an extension on the understanding that what was being asked was a time-limited waiver,” she told Intellectual Property Watch. “The [2011 IFPMA] statement highlights the importance of TRIPS implementation and advises that ‘such an extension should be used to align implementation across all areas of technology, to ensure a consistent approach’.”

Advocate Perspective

According to Ellen ‘t Hoen, former director of the Medicines Patent Pool and past head of the Médicins Sans Frontières access to essential medicines campaign, “these two extensions live alongside.” This unusual situation could in fact play in favour of LDCs, she told Intellectual Property Watch.

“What LDCs will most likely do is to also ask for an extension for pharmaceuticals and data protection closer to the 2016 deadline,” she said. They could ask for a longer deadline than 2021 for pharmaceuticals, for example, until they have ‘graduated’ to developing country status, “which is what they tried to do for the entire TRIPS agreement.” LDCs can opt to protect pharmaceutical products but they can choose not to protect them, she said. “Many of them have already patent laws on the books, but what paragraph 7 of the Doha Declaration has done on a very wide scale, is to allow LDCs not to enforce the patents that they have.”

“And countries, on a much wider scale than is generally understood have made use of that provision in their day to day procurements, in particular for antiretroviral drugs,” she said.

Paragraph 7 “has given the generic suppliers the insurance that they have the legal protection do supply their products.” The new extension only adds to the important steps achieved by paragraph 7, she said. “However, until LDCs can produce medicines they will remain dependent on the production and export of low cost generics from elsewhere, mostly developing countries that have the obligation to provide pharmaceutical patent protection.”

“Therefore licensing of these patents for example through the Medicines Patent Pool will remain important. It is also crucial that countries that grant compulsory licenses ensure the products produced under these licenses can be exported to other countries such as LDCs that need access to these products,” she said.

“It remains to be seen whether LDCs are going to proactively use this legal space that has been given to them to review and amend their patent laws and design their IP laws, not only for patents, so that it reflects their level of technological development and their health needs.”

Academic Perspective

Prof. Fred Abbott of Florida State University Law School said: “When you have several formal decisions covering overlapping subject matter, there are going to be questions regarding the legal relationship between them.”

“Notwithstanding the unfortunate press release issued by the European Union on June 11, 2013, the new extension manifestly does not establish an enforceable WTO legal obligation on LDCs that precludes rollback of existing intellectual property legislation and rules (except with respect to national treatment and most favoured nations), he told Intellectual Property Watch.

“The EU press release made the assertion that the June 11, 2013 decision ‘does not affect the transition period for patents for pharmaceutical products, which was agreed in 2002; LDCs will not have to protect these patents until 2016.’ But, the June 11, 2013 decision includes patents within its subject matter scope, so it is rather difficult to understand why LDCs would be required to provide patent protection for pharmaceutical products (or any other products) in 2016 since the general extension runs to July 1, 2021.”

“Because the June 11, 2013 decision allows LDCs to roll back existing levels of protection, they can elect to reduce existing levels of patent protection up until July 1, 2021, including for pharmaceutical subject matter,” he said.

“The June 11, 2013 decision states that it is ‘without prejudice’ to the June 27, 2002 TRIPS Council extension. ‘Prejudice’ is a negative or pejorative term, signaling adverse effect,” he said.” “Therefore, the June 11, 2013 decision must not diminish the rights granted to LDCs under the 2002 decision. The June 27, 2002 decision made clear that patents LDCs may have granted with respect to pharmaceutical products, and regulatory data protections, do not need to be enforced.”

“Particularly in light of statements such as that made by the EU on June 11, 2013, there is a value to this confirmation of the right of LDCs under WTO law not to enforce pharmaceutical patents and regulatory data protections. LDCs will need to assess whether to seek a specific additional extension of the June 27, 2002 TRIPS Council decision,” Abbott said. “The process of assessment should probably be initiated soon.”

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